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Abstract Details

Effect of Longer-term Ofatumumab Treatment on Disability Progression and Brain Volume Change
Multiple Sclerosis
S16 - MS Clinical Trials and Therapeutics (2:36 PM-2:48 PM)
009

In the ASCLEPIOS I/II core studies, ofatumumab (3-/6-month[m] CDW: 10.90%/8.15%) delayed disability accrual compared with teriflunomide (3/6mCDW: 14.98%/11.95%). PIRA was the main contributor to overall 3m/6mCDW.

To assess confirmed disability worsening (CDW), progression independent of relapse activity (PIRA), relapse-associated worsening (RAW), and brain volume change (BVC) in relapsing multiple sclerosis patients receiving ofatumumab for up to 5 years.

Results are presented for up to 4 years (ASCLEPIOS + ALITHIOS open-label extension) in patients on continuous ofatumumab and those switched from teriflunomide in the extension; 4- and 5-year data to be presented at congress. 6mCDW, PIRA (CDW events without confirmed relapses prior to CDW), RAW (event onset <90 days from a relapse), and BVC (percent brain volume change[PBVC] and annualized rates of change in brain volume[ABVC]) were assessed (full analysis set).

Of 1882 patients randomized in ASCLEPIOS I/II (ofatumumab/teriflunomide:946/936), 1367 entered ALITHIOS (continuous/switch:690/677). Most patients were free from 3m/6mCDW events during the studies (ofatumumab: 85.0%; teriflunomide: 80.7%). Up to 4 years (cut off: 25-Sep-2021), 119/946 (12.6%) and 148/936 (15.8%) patients had 6mCDW in the continuous and switch groups, respectively. In the continuous group, the 6mPIRA Kaplan-Meier cumulative event rate[KM-CER] remained low (11.0%) and 6mPIRA accounted for the majority of patients, i.e., 86/119 (72.3%; core:65.9%; extension:92.9%) whereas 6mRAW (KM-CER: 3.5%) accounted for only 30/119 (25.2%) patients (core:30.8%; extension:7.1%). Up to 4 years, overall mean PBVC remained low, –1.42% and –1.62% for the continuous and switch groups, respectively (at week 240). ABVC for continuous ofatumumab remained low in the core (–0.34%/year) and extension (–0.28%/year). In the switch group, ABVC was –0.42%/year(core) and –0.29%/year(extension).

With longer-term ofatumumab treatment, disability progression was predominantly PIRA, the annual rate of BVC remained low, and low rates of CDW/PIRA indicated that most patients remained free from disease progression. Outcomes favored early, compared with later, initiation with ofatumumab.

Authors/Disclosures
Jeffrey Alan Cohen, MD (Cleveland Clinic)
PRESENTER
Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gossamer Bio. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage.
Stephen L. Hauser, MD (UCSF Weill Institute for Neurosciences) Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NGM Bio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pheno Therapeutics. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Accure. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alector. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Neurona. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Roche that is relevant to AAN interests or activities. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Novartis that is relevant to AAN interests or activities.
Ronald Zielman Dr. Zielman has received personal compensation for serving as an employee of Novartis.
Ayan Das Gupta (Novartis Healthcare) Ayan Das Gupta has received personal compensation for serving as an employee of Novartis Health Care Pvt. Ltd.
Amin Azmon Amin Azmon has nothing to disclose.
Jing Xi, PhD (Novartis) Dr. Xi has received personal compensation for serving as an employee of Novartis.
Gina Mavrikis Cox, PhD (Novartis Pharmaceuticals) Dr. Mavrikis Cox has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Dr. Mavrikis Cox has stock in Novartis Pharmaceuticals.
Derrick Robertson, MD Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Greenwich Biosciences. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mallinckrodt. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for PRIME CME. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for McVeigh. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Mccumber. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Goodis. The institution of Dr. Robertson has received research support from Biogen. The institution of Dr. Robertson has received research support from EMD Serono. The institution of Dr. Robertson has received research support from Jansenn. The institution of Dr. Robertson has received research support from Genentech. The institution of Dr. Robertson has received research support from Patient-Centered Outcomes Research Institute. The institution of Dr. Robertson has received research support from Novartis. The institution of Dr. Robertson has received research support from Sanofi Genzyme. The institution of Dr. Robertson has received research support from TG Therapeutics. The institution of Dr. Robertson has received research support from Prime. The institution of Dr. Robertson has received research support from Greenwich Biosciences. The institution of Dr. Robertson has received research support from Atara Biotherapeutics. The institution of Dr. Robertson has received research support from CorEvitas. The institution of Dr. Robertson has received research support from Anokion. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Consortium of Multiple Sclerosis Centers. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Multiple Sclerosis Association of America.
Heinz Wiendl, MD, FAAN (University of Muenster) Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson / Janssen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Idorsia. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NexGen. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Worldwide Clinical Trials. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gossamer Bio. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for LTS. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sangamo. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz-Hexal. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cellerys. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Toleranzia. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Roche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from European Union. The institution of Dr. Wiendl has received research support from Argenx. The institution of Dr. Wiendl has received research support from CSL Behring. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from UCB. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care.
Ludwig Kappos, MD, FAAN ( RC2NB, University Hospital Basel) The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care.